Personalizing preset meal sizes in insulin delivery system

ABSTRACT

A method may include displaying at least three icons on a user interface of a mobile device, including a first icon associated with the at least three icons associated with a first carbohydrate level, a second icon associated with the at least three icons associated with a second carbohydrate level, and a third icon associated with the at least three icons associated with a third carbohydrate level. The method may also include receiving a user selection of one of the three icons through the user interface of the mobile device, and determining an insulin bolus level from the user selection. The method may also include communicating the insulin bolus level to an insulin delivery device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/717,845, filed Sep. 27, 2017, which claims the benefit of priority tothe Sep. 27, 2016 filing date of the U.S. Patent Provisional ApplicationSer. No. 62/400,366, titled “PERSONALIZING PRESET MEAL SIZES IN INSULINDELIVERY SYSTEM” (the '366 Provisional Application), is hereby madepursuant to 35 U.S.C. § 119(e). The entire disclosure of each of whichis hereby incorporated herein.

TECHNICAL FIELD

This invention relates to the personalizing of preset meal sizes for auser to enter meal data into an insulin delivery system. For example,one or more meal icons can be personalized to describe an amount orrange of amounts of carbohydrates for an insulin bolus calculation.

BACKGROUND

Diabetes mellitus is a chronic metabolic disorder caused by an inabilityof a person's pancreas to produce sufficient amounts of the hormone,insulin, such that the person's metabolism is unable to provide for theproper absorption of sugar and starch. This failure leads tohyperglycemia, i.e., the presence of an excessive amount of analyte,such as glucose, within the blood plasma. Persistent hyperglycemia hasbeen associated with a variety of serious symptoms and life threateninglong-term complications such as dehydration, ketoacidosis, diabeticcoma, cardiovascular diseases, chronic renal failure, retinal damage andnerve damages with the risk of amputation of extremities.Self-monitoring of blood glucose and the self-administration of insulinis the typical method for treating diabetes. In order to assist withthis self-treatment, many diabetes-related devices (e.g., blood glucosemeters, insulin pumps, etc.) are equipped with insulin bolus calculatorsthat have the user input a number of carbohydrates consumed (or about tobe consumed) and the bolus calculator outputs a recommended size for theinsulin bolus dosage. Although bolus calculators remove some of thecalculations that need to be made by the user in determining anappropriate insulin bolus dosage, bolus calculators still burden theuser with the mental task of determining the number of carbohydrates intheir meal. Accordingly, there is a need for methods, systems, anddevices that further reduce the cognitive burden on the user whileimproving the accuracy of a recommended insulin bolus dosage.

BRIEF SUMMARY

Some embodiments include an insulin delivery system that includes aninsulin delivery device adapted to receive insulin and deliver insulinsubcutaneously; a user interface in communication with the insulindelivery device and adapted to send the insulin delivery device bolusinsulin instructions, the user interface including multipleuser-selectable icons or buttons each representing an amount ofcarbohydrates; memory to store one or more user-specific dosageparameter; and a processor in communication with the memory and adaptedto receive blood glucose data, the processor being adapted to determinethe amount of carbohydrates associated with each of the user-selectableicons or buttons based on at least one of the user-specific dosageparameters, the processor further being adapted to update the amount ofcarbohydrates associated with each of the user-selectable icons orbuttons based upon the blood glucose data.

In some embodiments, the user-selectable icons or buttons each representan amount of carbohydrates in 5 gram or 10 gram increments. In someembodiments, the amount of carbohydrates represented by each of theicons is determined based on an insulin Sensitivity Factor (ISF), a CarbRatio (CR), a body weight, an age, a total daily basal dose (TDBD),and/or a combination thereof of a person with diabetes (PWD).

In some embodiments, the processor is further configured to determine aninsulin delivery amount based on an amount of carbohydrates associatedwith a selected one of the user selectable icons or buttons and/or theblood glucose data.

In some embodiments, the user-selectable icons or buttons each representan amount of carbohydrates rounded to the nearest 5 grams.

In some embodiments, the insulin delivery system may include a glucosemonitor adapted to monitor the glucose level of a person with diabetesand provide blood glucose data to the processor.

In some embodiments, the amount of carbohydrates associated with each ofthe user-selectable icons is determined from postprandial blood glucosedata.

Some embodiments may include a method that includes displaying at leastthree icons on a user interface of a mobile device, including a firsticon associated with the at least three icons associated with a firstcarbohydrate level, a second icon associated with the at least threeicons associated with a second carbohydrate level, and a third iconassociated with the at least three icons associated with a thirdcarbohydrate level; receiving a user selection of one of the three iconsthrough the user interface of the mobile device; determining an insulinbolus level from the user selection; and communicating the insulin boluslevel to an insulin delivery device.

In some embodiments, the method may include receiving blood glucosedata; wherein the insulin bolus level is determined in part from theblood glucose data.

In some embodiments, adjusting the first carbohydrate level, the secondcarbohydrate level, and the third carbohydrate level based on an insulinSensitivity Factor (ISF), a Carb Ratio (CR), a body weight, an age, atotal daily basal dose (TDBD) (which can be characterized as a rate),and/or a combination thereof of a person with diabetes (PWD).

In some embodiments, the insulin bolus level is communicated to theinsulin delivery device in response to a user selection indicatingdelivery of the insulin, wherein the user selection includes a fail-safeprocedure.

In some embodiments, the insulin bolus level is communicated to theinsulin delivery device in response to a user selection indicatingdelivery of the insulin, wherein the user selection includes a pluralityof taps or gestures from a user.

In some embodiments, the first carbohydrate level is rounded to thenearest 5 grams, the second carbohydrate level is rounded to the nearest5 grams, and the third carbohydrate level is rounded to the nearest 5grams.

In some embodiments, the method may include receiving postprandial bloodglucose data; and adjusting at least one of the first carbohydratelevel, the second carbohydrate level, and the third carbohydrate levelbased on the postprandial blood glucose data.

In some embodiments, the method may include the insulin bolus level isdetermined from one or more of the following factors the number ofcarbohydrates divided by the PWD's carbohydrate-to-insulin ratio, adifference between the current blood glucose level and a target bloodglucose level divided by the PWD's insulin sensitivity factor, a readingfrom a blood glucose meter (BGM), data from a continuous glucose monitor(CGM), data from a flash glucose monitor, blood glucose trend data,Insulin on Board (IOB) data, Carbohydrates on Board (COB) data, whetherthe PWD is or plans to exercise, whether the PWD is sick, whether thePWD is pregnant, whether the PWD is experiencing menses, and/or whetherthe PWD has consumed certain medications.

BRIEF DESCRIPTION OF THE DRAWINGS

Example embodiments will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1 provides an example graph illustrating recorded meal sizes forboluses;

FIG. 2 provides an example graph illustrating percentages of users thatrounded meal sizes for boluses;

FIG. 3 provides an example graph illustrating a relationship between aninitial basal rate and a meal group size;

FIG. 4A illustrates an example interface for inputting a bolus;

FIG. 4B illustrates another example interface for inputting a bolus;

FIG. 4C illustrates another example interface for inputting a bolus;

FIG. 4D illustrates an example interface for initiating a bolus; and

FIG. 4E illustrates an example interface while a bolus is beingdelivered.

DETAILED DESCRIPTION

Devices, systems, and methods provided herein are adapted to reduce thecognitive burden on a user seeking to administer insulin for a mealwhile improving the accuracy of insulin bolus recommendations. In somecases, devices, systems, and methods provided herein can provide aplurality of preset meal sizes represented as icons or buttons for theuser to select, which can represent the size of a typical meal for theuser, a larger meal for the user, or a small meal for the user (andoptionally tiny meals or extra-large meals for the user). In some cases,the number of carbohydrates assigned to each preset icon or button canbe personalized for the user based on other user-specific dosageparameters entered by the user for an insulin delivery system (e.g.,total daily basal dosage of insulin (e.g., U/day), a total daily dose ofinsulin, a carbohydrate ratio, an insulin sensitivity factor, a glucosesetpoint, or a combination thereof). In some cases, the number ofcarbohydrates assigned to each preset icon or button can be personalizedover time based on estimations of the size of each meal consumed whenthat icon or button is selected based on a glucose response after theconsumption of each meal. In some cases, the number of carbohydratesassigned to each preset icon or button can be rounded to the nearest 5grams of carbohydrates. In some cases, a user may manually enterpersonalized meal sizes for a number of user selectable icons orbuttons. In some cases, a display can include the number ofcarbohydrates assigned to each preset icon or button. In some cases,after a user selects an icon, the user can select anotheruser-selectable icon or button to deliver the recommended insulin bolusdose. In some cases, the user can modify the recommended insulin bolusdose prior to administering the bolus dose and select anotheruser-selectable icon or button to deliver the altered insulin bolusdose. In some cases, the user can manually input a number ofcarbohydrates for a specific meal and modify number of carbohydratesassigned to a user-selectable icon or button. In some cases, a boluscalculation can use blood glucose data (e.g., from a BGM or estimatedfrom a CGM) to adjust the bolus calculation to account for an elevatedor low blood glucose level, which can optionally be displayed as aseparate calculation separate from the calculation of the part of thebolus that is due to the consumption of carbohydrates. In some cases,methods, systems, and devices provided herein can use glucose data(e.g., from a continuous glucose monitor or flash glucose monitor) toautomate the delivery of basal insulin.

A review of real user meal inputs from users of an insulin deliverysystem including a bolus calculator can reveal that users typicallyenter meal sizes in increments of 5 grams. This bias towards incrementsof 5 grams reveals that many users of bolus calculators do not feelconfident in their ability to accurately calculate their carbohydrateconsumption down to 1-gram increments. A study of 969 subjects having245,397 meal inputs revealed that 64% of those meals were recorded in 5g increments, as depicted in FIG. 1. This data set also revealed that65% of users rounded to the nearest 5 g at least 50% of the time and 20%always rounded to the nearest 5 g, as shown in FIG. 2.

Moreover, even if more users felt comfortable in attempting to make morespecific estimations of the carbohydrate content of the foods that theyselect to eat, there is little data to suggest that these users wouldtypically be within 5 grams of the actual carbohydrate count. Forexample, “Can children with type 1 diabetes and their caregiversestimate the carbohydrate content of meals and snacks?” C. E. Smart, K.Ross, J. A. Edge, B. R. King, P. McElduff, and C. E. Collins, DiabeticMedicine, 27, No. 3 (2010) pp. 38-353 illustrates the range or errorthere is in children having type 1 diabetes estimating the number ofcarbohydrates in meals and snacks.

Devices, systems, and methods provided herein can in some cases includeuser-selectable icons or buttons that describe (or represent) the sizeof a meal (e.g., in grams) in more subjective terms. In some cases, auser-selectable icon can be labeled as a medium sized meal or as atypical meal. In some cases, a user-selectable icon can be labeled as asmall meal, a smaller meal, or a tiny meal. In some cases, auser-selectable icon can be labeled as a large meal, a larger meal, oran extra-large meal. In some cases, a user interface for boluscalculations can include a plurality of user-selectable icons or buttonsthat are each programmed with an amount of carbohydrates that arepersonalized for the subjective interpretation for that user. Forexample, some users might have a typical or medium sized meal of 50grams while others might have a typical or medium sized meal of 20grams. Additionally, users might have different subjectiveinterpretations of what is a small meal, a medium meal, and a large mealfor that specific user. Accordingly, by personalizing the sizes of mealsfor that specific user such that it matches the user's subjectiveunderstandings, devices, systems, and methods provided herein canachieve better bolus dose recommendations without burdening the user totry to estimate a number of carbohydrates for that particular meal.

The personalizing of one or more meal size user-selectable icons orbuttons can be achieved using any suitable method. In some cases, anumber of carbohydrates assigned to each user-selectable icon or buttoncan be initially set at a predetermined starting point or can bedetermined based on entered user information, and then iterativelyadjusted upward or downward based upon the glycemic response to thatselected meal size and bolus over time.

Initial settings for one or more user-selectable icons or buttonsincluded on a device or in a system provided herein can be preset topredetermined values or ranges (e.g., small=20 g or 15-25 g, medium=30 gor 30-45 g, large=50 g or 50-75 g, and extra-large=80 g or 80-100 g) orcan be set based on entered user data or based on one or moreuser-specific dosage parameters entered into a device or system providedherein. In some cases, initial settings for the one or moreuser-selectable icons or buttons can be based on an initially entered ordetermined and programmed total daily basal dose (TDBD)/basal rate(e.g., U/day).

FIG. 3 depicts a chart 300 illustrating example settings for 4user-selectable icons or buttons based on an initially entered ordetermined TDB rate. In some cases, the preset values can be based onthe Insulin Sensitivity Factor (ISF), Carb Ratio (CR), body weight, age,TDBD, and/or a combination thereof of the person with diabetes (PWD).

FIG. 3 illustrates the relationship between Basal Rates (BR) in units of[U/day] and Geometric Mean Meal Size μ*_(MS) in units of [g](illustrated as 310 in FIG. 3) as characterized by the linecorresponding to the major axis of the hyperellipsoid:μ*_(MS)=12.1*BR^(0.387). The relationship between the Geometric MeanMeal Size and Geometric Standard Deviation Meal Size (σ*_(MS)) is:σ*_(MS)=1.92−μ*_(MS)/186. FIG. 3 includes the Geometric Mean Meal Sizeas 310 and two times the Geometric Standard Deviation Meal Size as 312 aand 312 b. Accordingly, FIG. 3 illustrates initial meal size groups ascorresponding to the 10% (as a small meal 350), 35% (as a medium meal340), 65% (as a large meal 330), and 90% percentiles (as an extra-largemeal 320) of the Meal Size distribution by combining the above equationsand rounding meal size groups to the nearest 5 grams. Thus, by way ofexample, for a user who had an initial basal rate of 10 U/day, theinitial setting for the small meal size button or icon may correspond to15 g (observed by the intersection of the small meal 350 with theinitial basal rate of 10 U/day), the initial setting for the medium mealsize button or icon may correspond to 25 g (observed by the intersectionof the medium meal 340 with the initial basal rate of 10 U/day), theinitial setting for the large meal size button or icon may correspond to35 g (observed by the intersection of the large meal 330 with theinitial basal rate of 10 U/day), and the initial setting for theextra-large meal size button or icon may correspond to 60 g (observed bythe intersection of the extra-large meal 320 with the initial basal rateof 10 U/day).

In some cases, the relationship between typical meal sizes and otheruser-specific dosage parameters can be determined according topopulation statistics. For example, using the study of 969 subjects andtheir entered meal sizes discussed above, the distribution of logtransformed Basal Rate (BR) in units of [U/day], Carb Ratio (CR) inunits of [g/U], Insulin Sensitivity Factor (ISF) in units of [mg/d1/U],and meal size (MS) in units of [g] can be represented using thefollowing multivariable normal, with mean and covariance matrices μ andΣ:

${\left. x \right.\sim{N\left( {\mu,\Sigma} \right)}};{\mu = \begin{bmatrix}\mu_{l\;{n{({BR})}}} \\\mu_{l\;{n{({CR})}}} \\\mu_{l\;{n{({ISF})}}} \\\mu_{l\;{n{({MS})}}}\end{bmatrix}}$ $\Sigma = \begin{bmatrix}\sigma_{l\;{n{({BR})}}}^{2} & \sigma_{{l\;{n{({BR})}}},{l\;{n{({CR})}}}} & \sigma_{{l\;{n{({BR})}}},{l\;{n{({ISF})}}}} & \sigma_{{l\;{n{({BR})}}},{l\;{n{({MR})}}}} \\\sigma_{{l\;{n{({BR})}}},{l\;{n{({CR})}}}} & \sigma_{l\;{n{({CR})}}}^{2} & \sigma_{{l\;{n{({CR})}}},{l\;{n{({ISF})}}}} & \sigma_{{l\;{n{({CR})}}},{l\;{n{({MR})}}}} \\\sigma_{{l\;{n{({BR})}}},{l\;{n{({ISF})}}}} & \sigma_{{l\;{n{({CR})}}},{l\;{n{({ISF})}}}} & \sigma_{l\;{n{({ISF})}}}^{2} & \sigma_{{l\;{n{({MR})}}},{l\;{n{({ISF})}}}} \\\sigma_{{l\;{n{({BR})}}},{l\;{n{({MR})}}}} & \sigma_{{l\;{n{({CR})}}},{l\;{n{({MR})}}}} & \sigma_{{l\;{n{({MR})}}},{l\;{n{({ISF})}}}} & \sigma_{l\;{n{({MS})}}}^{2}\end{bmatrix}$

The mean and covariance matrices computed using robust statistics, withcorresponding μ*, σ*, and correlation matrices ρ are:

$\mu = {{\begin{bmatrix}{{3.0}111} \\{{2.3}757} \\{{3.8}645} \\{{3.6}622}\end{bmatrix}\mspace{14mu}\Sigma} = \begin{bmatrix}{{0.2}843} & {{- {0.1}}657} & {{- {0.2}}216} & {{0.0}855} \\{{- {0.1}}657} & {{0.1}978} & {{0.1}863} & {{- {0.0}}412} \\{{- {0.2}}216} & {{0.1}863} & {{0.2}968} & {{- {0.0}}82} \\{{0.0}855} & {{- {0.0}}412} & {{- {0.0}}82} & {{0.1}532}\end{bmatrix}}$ ${\mu^{*} = \begin{bmatrix}{20{.3}U\text{/}{day}} \\{10.8\mspace{14mu} g\text{/}U} \\{47.7\mspace{11mu}\frac{mg}{dl}\text{/}U} \\{38.9\mspace{14mu} g}\end{bmatrix}};{\sigma^{*} = {{\begin{bmatrix}{{1.7}0} \\{{1.5}6} \\{{1.7}2} \\{{1.4}8}\end{bmatrix}\mspace{14mu}\rho} = \begin{bmatrix}1 & {{- {0.7}}0} & {{- {0.7}}6} & {{0.4}1} \\{{- {0.7}}0} & 1 & {{0.7}7} & {{- {0.2}}4} \\{{- {0.7}}6} & {{0.7}7} & 1 & {{- {0.3}}8} \\{{0.4}1} & {{- {0.2}}4} & {{- {0.3}}8} & 1\end{bmatrix}}}$

Using these equations and rounding to the nearest 5 grams ofcarbohydrates, the chart of FIG. 3 can be obtained, which shows thedistribution σ for meal sizes. It is contemplated, however, thatadditional population studies can be conducted to create better and/ordifferent correlations between the typical, large, medium, and smallmeal sizes for a PWD based on their TBD, weight, age, ISF, CR, or acombination thereof.

In some cases, the number of carbohydrates associated with eachuser-selectable icon or button can be displayed on and/or adjacent tothe user-selectable icon or button, which can help a user understand howto use the insulin delivery device or system to avoid deskilling theuser. For example, seeing the number of carbohydrates assumed for eachmeal size helps a user that thinks about meals in terms of carbohydratesto adjust to using buttons to indicate a size of a meal. Additionally,by starting with display numbers rounded to the nearest 5 grams, theuser can perceive that precision is not required, thus also reducing thecognitive burden on the user. Additionally, as the system iterates topersonalize the amount of carbohydrates for each particularuser-selectable icon or button, the system can adjust these numbers bysmaller units (e.g., by 1 gram) to demonstrate to the user that thesystem is adjusting the number of carbohydrates associated withuser-selectable icon or button.

Methods, systems, and devices provided herein can update the number ofcarbohydrates associated with each user-selectable icon or button usingany suitable method. In some cases, methods, systems, and devices canuse postprandial blood glucose data (e.g., between 1 hour and 3 hoursafter an announced meal) to evaluate whether the PWD likely consumedsignificantly more or significantly less carbohydrates than programmedfor the user-selectable icon or button (e.g., +/−10%, +/−15%, +/−20%,etc., consumer carbohydrates). In some cases, one or more postprandialblood glucose thresholds can be used to evaluate the match between theamount of carbohydrates consumed and the amount of carbohydratesassociated with a selected user-selectable meal icon or button. Forexample, methods, devices, and systems provided herein can ask a userfor a postprandial blood glucose reading from a blood glucose meter. Insome cases, methods, devices, and systems provided herein can receivepostprandial blood glucose data from a continuous glucose monitor orflash glucose monitor. In some cases, methods, systems, and devicesprovided herein can use a single postprandial blood glucose data pointand compare that to one or more upper thresholds and one or more lowerthresholds for that period of time to determine whether the number ofcarbohydrates associated with that user-selectable meal icon or buttonshould be adjusted upward or downward. For example, if a user selects atypical meal icon indicating a meal of 30 grams of carbohydrates, butthe 2-hour postprandial blood glucose reading is above 200 mg/dL, thenumber of grams associated with that icon or button might be adjustedupward by 2 grams, if it is above 170 mg/dL, it might be adjusted upwardby 1 gram, if it is below 130 mg/dL, it might be reduced by 1 gram, andif it is below 100 mg/dL, it might be reduced by 2 grams. Accordingly,over time the meal icons may be adjusted to more closely resemble theuser's typical consumption patterns. The particular thresholds can bedetermined based on the postprandial time, the number of gramsassociated with the meal icon or button, the CR, ISF, and TDB, andsetpoint of the PWD, etc.

In some cases, methods, systems, and devices provided herein canadditionally automate insulin delivery using blood glucose data.Methods, systems, and devices provided herein can use any suitablealgorithm to automate insulin delivery. In some cases, the blood glucosedata can be from a continuous glucose monitor or flash glucose monitor.In some cases, methods, systems, and devices provided herein can deliverbasal insulin doses throughout the day that vary based on the recentblood glucose data (e.g., within the last hour), estimations of theamount of active insulin in the PWD's body (e.g., Insulin On Board(IOB)), estimations of the amount of active carbohydrates (e.g.,carbohydrates on board), an Insulin Sensitivity Factor (ISF), aCarbohydrate-to-Insulin Ratio (CR), and other user-specific dosageparameters. In some cases, methods, devices, and systems provided hereincan be a proportional-integral-derivative (PID) controller. In somecases, methods, devices, and systems provided herein can predict futureblood glucose levels for different insulin delivery amounts or schedulesand can pick an insulin delivery amount or schedule that minimizes avariation from a set point or that reduces the risk of future bloodglucose levels exiting a predetermined range of blood glucose levels. Anexample of a suitable control algorithm is described in U.S. applicationSer. No. 15/601,282, which is incorporated by reference herein in itsentirety.

Methods, devices, and systems provided herein can use any suitableinsulin delivery device or artificial pancreas system or closed loopinsulin delivery system. In some cases, the insulin delivery device canbe an insulin pump. In some cases, the insulin delivery device can be aninsulin pump having a controller adapted to automate basal insulindelivery based on communications from a CGM or flash glucose monitor,such as described in U.S. application Ser. No. 15/601,282. Additionallyor alternatively, the basal insulin delivery may be based oncommunication from a flash glucose monitor. In some cases, the insulindelivery device can be a smart insulin pen.

Methods, devices, and systems provided herein can in some cases have auser interface on a remote controller device (e.g., a smartphone) asdescribed in U.S. application Ser. No. 15/601,282. In some cases, aremote controller device can wirelessly communicate (e.g., via BluetoothLow Energy, Near-Field Communications, etc.) with an insulin deliverydevice (e.g., an insulin pump or a smart insulin pen) to send a requestor instruction to the insulin delivery device regarding the informationneeded to deliver the calculated amount of insulin bolus. In some cases,methods, systems, and devices provided herein can include an insulinpump as the insulin delivery device and allow a user to deliver a boluswithout the user directly accessing the insulin pump. In some cases,methods, systems, and devices provided herein can require a user toconfirm a bolus delivery on an insulin pump before the bolus isdelivered. In some cases, methods, systems, and devices provided hereinmay send a setting or instruction to a smart insulin pen (with orwithout allowing the user to alter the setting), but require that theuser use the smart insulin pen to actually deliver each bolus.

A user interface on a remote controller device can include theuser-selectable meal icons or buttons described above. In some cases, aremote controller device can be a wrist watch. In some cases, methods,devices, and systems provided herein can, in some cases, include a userinterface that is part of an insulin delivery device that includes theuser-selectable icons or buttons described above. In some cases, theuser interface having the user selectable icons or buttons describedabove can be included on other devices, such as a BGM, a CGM, a flashglucose monitor, an insulin pump, a smart insulin delivery pen, or anyother device associated with a PWD.

FIGS. 4A through 4E illustrate various example interfaces in accordancewith the present disclosure. For example, FIG. 4A illustrates an exampleinterface for inputting a bolus; FIG. 4B illustrates another exampleinterface for inputting a bolus; FIG. 4C illustrates another exampleinterface for inputting a bolus; FIG. 4D illustrates an exampleinterface for initiating a bolus; and FIG. 4E illustrates an exampleinterface while a bolus is being delivered.

As illustrated in FIGS. 4A and 4B, a user can toggle between (e.g., withbuttons 451) a user interface 401 (of FIG. 4A) with a quick bolus screenhaving user selectable icons 411, 412, 413, and each represent adifferent number of carbohydrates (e.g., 10 g, 30 g, 50 g, and 80 g),and a user interface 402 (of FIG. 4B) with a basic bolus screen having afirst field 421 that allow a user to enter grams of carbohydrates and/ora second field 431 to display or enter a blood glucose level, which may,for example, be received from a BGM, CGM, or flash glucose monitor. Asdiscussed above, when first starting to use methods, systems, anddevices described herein with a PWD, the settings of the selectableicons can be based on the user's TDB (e.g., as shown in FIG. 3) or otheruser-specific dosage parameters. Over time, the number of carbohydratescan be updated based on postprandial blood glucose data being over orunder one or more thresholds. Although shown as 10 g, 30 g, 50 g, and 80g in FIG. 4A, over time these numbers might eventually read, forexample, as 8 g, 34 g, 47 g, and 85 g. In some cases, methods, systems,and devices provided herein may adjust adjacent user-selectable icon orbutton carbohydrate values to ensure a differentiation. For example, ifthe medium icon or button 412 is personalized up, the large icon orbutton 413 may also be adjusted upward to maintain a minimumdifferentiation between the amount of carbohydrates more than the mediumbutton (e.g., at least 5 g, at least 10 g, or at least some other numberof grams). In some cases, after selecting one of the icons 411, 412,413, and/or 414, the user interface 401 may include a field 418 that maydisplay a number of units of insulin to be delivered corresponding tothe selected icon.

In some cases, the different number of carbohydrates associated witheach of the user selectable icons 411, 412, 413, and/or 414 can be basedon user-specific dosage parameters entered for the PWD when they firststart the system. In some cases, the different number of carbohydratesassociated with each user selectable icon can become personalized overtime based on postprandial blood glucose data. In some cases, thedifferent number of carbohydrates associated with each user selectableicon can vary based on the time of day (e.g., meal sizes might becomepersonalized differently if the meal is in the morning vs. in theevening). In this example, each of the user selectable icons may includea graphic (e.g., a fork, a circle, a food item, or any other graphic)that has a size proportional to or related to the relative number ofcarbohydrates represented by the selectable icon. While four icons (411,412, 413, and 414) are displayed, any number of icons may be used thatrepresent different carbohydrate values. As discussed above thecarbohydrate values represented by the icons may be predetermined and/oradjusted over time based on the user's postprandial blood glucose data.In some cases, an icon corresponding to a correction bolus only can bedisplayed.

FIG. 4B illustrates the user interface 402 where a user has toggled to abasic bolus screen where the user can enter a number of carbohydrates inthe field 421 and optionally enter a blood glucose reading in the field431. The user interface 402 can display the corresponding amount ofinsulin to be delivered for the entered number of carbohydrates andblood glucose level. In some cases, CGM data or flash glucose monitordata can be used in place of or in addition to data input in the field431 corresponding to a blood glucose reading for the calculation of abolus. In some cases, the user interface can indicate how much of abolus is due to the consumed carbohydrates and how much is beingadministered to correct the current blood glucose level. In some cases,a user using user interfaces 401 and/or 402 of FIGS. 4A and 4B will beshown the number of units of insulin to be delivered (optionallyexplaining the calculation, which may include a correction component dueto CGM data or flash glucose monitor data) before the user is allowed toissue the bolus command.

FIG. 4C illustrates another example interface 403 for inputting a bolus.For example, in some cases, a user might want to enter a more specificamount of carbohydrates, thus methods, systems, and devices providedherein can allow the user to enter a specific amount of carbohydrates.For example, as illustrated in FIG. 4C, an adjustable dial 461 may popup in the user interface 403 in response to a user pressing and holdingan icon (e.g., the icon 414) rather than tapping the icon. A featuresuch as the adjustable dial may provide multiple carbohydrate values in5-gram increments centered on the carbohydrate value represented by theicon. For example, if the icon represents 60 grams of carbohydrates thenthe associated pop up dial may include values greater than and less than60 grams in 5 gram increments. In some cases, the 5-gram increments foreach button are bound by the different number of carbohydratesassociated with each of the adjacent user selectable icons. In somecases, a consistent selection of a different number of carbohydrates fora meal size can result in the number of carbohydrates associated withthat user selectable icon updating to reflect a meal size typicallyselected by that user when using that icon (e.g., the meal size that isthe median meal size, the meal size that is the median meal size, or themeal size that is the mode of meal sizes selected by that user). It maybe that some users may select meal sizes in 5-gram increments, but otherusers may just quickly tap one of the icons (perhaps assuming that it isclose enough and that adjustments to basal insulin rates will compensatefor any discrepancy between the number of consumed carbohydrates and thenumber selected). In these and other embodiments, methods, devices, andsystems of the present disclosure may provide functionality thatservices either approach to entering information to receive a bolus ofinsulin.

As noted above, the user device may calculate an insulin bolus dosecorresponding to the selected carbohydrate amount. The insulin bolusdose may include a meal component (e.g., the number of carbohydratesdivided by the PWD's carbohydrate-to-insulin ratio) and a correctioncomponent (e.g., the delta between the current blood glucose level and atarget blood glucose level divided by the PWD's insulin sensitivityfactor). In some cases, the calculation of a correction component mayrequire a recent (e.g., within 15 minutes) reading from a blood glucosemeter (BGM). In some cases, a correction component may be based on datafrom a continuous glucose monitor (CGM), a flash glucose monitor, or anyother sensor configured to provide blood glucose levels. In some cases,a bolus calculation may consider blood glucose trend data, Insulin onBoard (IOB), and/or Carbohydrates on Board (COB). In some cases, thebolus calculation can consider certain physiological conditions for thePWD, such as whether the PWD is or plans to exercise, whether the PWD issick, whether the PWD is pregnant, whether the PWD is experiencingmenses, and/or whether the PWD has consumed certain medications.

FIG. 4D illustrates an example interface 404 for initiating a bolus. Forexample, the user interface 404 may require the user to tap multiplebuttons 471 (e.g., the buttons 471 a, 471 b, and/or 471 c) prior todelivery of insulin. The tapping of multiple buttons in a certainpattern may mitigate against unintentional deliveries of insulin. Inthis example, the user interface displays icons with the words: “ready,”“set,” and “go.” The second icon may be unselectable until the firsticon has been selected. The third icon may be unselectable until thesecond icon has been selected. Once the three icons have been selectedan insulin bolus dose may be delivered to the user, for example, via aninsulin delivery pump. Once the three icons have been selected, theapplication executing on the user device may send a message to aninsulin delivery pump, for example, via a wireless communication device(such as an antenna), and/or chipset (such as a Bluetooth device (e.g.,Bluetooth Low Energy, Classic Bluetooth, etc.), a Near-fieldcommunication (NFC) device, an 802.6 device (e.g., Metropolitan AreaNetwork (MAN), a Zigbee device, etc.), a WiFi device, a WiMax device,cellular communication facilities, etc.), and/or the like, that includesthe amount of insulin to be delivered to the user. The requirement totap multiple buttons may reduce the chances that insulin isinadvertently delivered to the user. The interface 404 may also includea field 481 that displays the number of units of insulin to be deliveredin the bolus. Additionally or alternatively, the interface 404 mayindicate whether or not the bolus includes a correction portion of thebolus and/or what portion of the bolus is for correction purposes (e.g.,to address a high blood glucose level).

In some cases, the order of the buttons 471 may be rearranged each timethe user delivers or a bolus, or on any other regular interval. Forexample, the first time a PWD delivers a bolus in the day the buttons471 may be in the order from left to right of 471 a (Ready), 471 b(Set), 471 c (Go); a second time in the day delivering a bolus, thebuttons 471 may be in the order from left to right of 471 c (Go), 471 b(Set), 471 a (Ready), etc.

FIG. 4E illustrates an example interface 405 while a bolus is beingdelivered. In some cases, the interface 405 may include an indicator ofthe progression of delivery of insulin. For example, the insulindelivery screen may include an icon 491 that illustrates a syringe, witha decreasing amount of fluid 492. Additionally or alternatively, theindicator may include a decreasing numerical percentage, a coloredcircle that is filling/emptying or being drawn/erased, or any otherdisplay or visual indicator of progress of delivering insulin.

In some cases, the interface 405 may include a button or icon 493 thatcan be selected to stop the delivery of insulin. In some cases, invokingthe button or icon 493 may trigger an alert or an alarm to the user thatthey interrupted the delivery of insulin and inquire whether or not theywould like to resume or complete the delivery of the bolus of insulin.

In some cases, a completion screen may be displayed after an insulinbolus has been delivered. Additionally or alternatively, a screen may bedisplayed that illustrates an alert or an alarm that a blood glucoselevel is high and a correction bolus may be advisable for the user.

In some cases, a user may invoke an app icon displayed on a home screenof a user device such as, for example, a smart phone. The user canselect the app icon via a touch screen or another user interface device,which results in execution of the corresponding application. In somecases, once executed on the user device, the application may include ahome screen or landing screen. The home screen may display various datasuch as, for example, the user's current blood glucose data as receivedfrom a BGM, CGM, or flash glucose monitor. Various other data may bepresented on the home screen, such as a calculated IOB, a blood glucosetrend, and/or previous insulin delivery amounts and/or times. The homescreen may also include a selectable button (or icon) that be tapped toallow the user to enter data regarding a meal bolus using a bolusscreen. The invocation of such a meal bolus button or icon may lead theuser to any of the screens of FIGS. 4A, 4B, 4C, etc.

The user interface described above can be used in an automated insulindelivery system adapted for use by a person having type 1 diabetes, butsome aspects of this user interface can used by a person having Type 2diabetes or gestational diabetes. In some cases, at least some aspectsof the bolus user interface described above can be used in in a mobileapplication to personalize the treatment of Type 2 diabetes.

The embodiments described herein may include the use of aspecial-purpose or general-purpose computer including various computerhardware or software modules, as discussed in greater detail below.

Embodiments described herein may be implemented using computer-readablemedia for carrying or having computer-executable instructions or datastructures stored thereon.

Such computer-readable media may be any available media that may beaccessed by a general-purpose or special-purpose computer. By way ofexample, and not limitation, such computer-readable media may includenon-transitory computer-readable storage media including Random AccessMemory (RAM), Read-Only Memory (ROM), Electrically Erasable ProgrammableRead-Only Memory (EEPROM), Compact Disc Read-Only Memory (CD-ROM) orother optical disk storage, magnetic disk storage or other magneticstorage devices, flash memory devices (e.g., solid state memorydevices), or any other storage medium which may be used to carry orstore desired program code in the form of computer-executableinstructions or data structures and which may be accessed by ageneral-purpose or special-purpose computer. Combinations of the abovemay also be included within the scope of computer-readable media.

Computer-executable instructions comprise, for example, instructions anddata which cause a general-purpose computer, special-purpose computer,or special-purpose processing device (e.g., one or more processors) toperform a certain function or group of functions. Although the subjectmatter has been described in language specific to structural featuresand/or methodological acts, it is to be understood that the subjectmatter defined in the appended claims is not necessarily limited to thespecific features or acts described above. Rather, the specific featuresand acts described above are disclosed as example forms of implementingthe claims.

As used herein, the terms “module” or “component” may refer to specifichardware implementations configured to perform the operations of themodule or component and/or software objects or software routines thatmay be stored on and/or executed by general-purpose hardware (e.g.,computer-readable media, processing devices, etc.) of the computingsystem. In some embodiments, the different components, modules, engines,and services described herein may be implemented as objects or processesthat execute on the computing system (e.g., as separate threads). Whilesome of the system and methods described herein are generally describedas being implemented in software (stored on and/or executed bygeneral-purpose hardware), specific hardware implementations or acombination of software and specific hardware implementations are alsopossible and contemplated. In the present description, a “computingentity” may be any computing system as previously defined herein, or anymodule or combination of modulates running on a computing system.

Any ranges expressed herein (including in the claims) are considered tobe given their broadest possible interpretation. For example, unlessexplicitly mentioned otherwise, ranges are to include their end points(e.g., a range of “between X and Y” would include X and Y).Additionally, ranges described using the terms “approximately” or“about” are to be understood to be given their broadest meaningconsistent with the understanding of those skilled in the art.Additionally, the term approximately includes anything within 10%, or5%, or within manufacturing or typical tolerances.

All examples and conditional language recited herein are intended forpedagogical objects to aid the reader in understanding the disclosureand the concepts contributed by the inventor to furthering the art, andare to be construed as being without limitation to such specificallyrecited examples and conditions. Although embodiments of the presentdisclosure have been described in detail, it should be understood thatthe various changes, substitutions, and alterations could be made heretowithout departing from the spirit and scope of the disclosure.

What is claimed is:
 1. An insulin delivery system comprising: an insulindelivery device; a mobile device in communication with the insulindelivery device, the mobile device comprising: a user interface; atleast one processor; and at least one non-transitory computer-readablestorage medium storing instructions thereon that, when executed by theat least one processor, cause the mobile device to: display a pluralityof user-selectable elements, each user-selectable element representing arespective meal size and associated with a respective different amountof carbohydrates; determine a plurality o f insulin delivery amounts,each insulin delivery amount deliverable responsive to a selection of arespective user-selectable element and determined based at leastpartially on the amount of carbohydrates associated with the respectiveuser selectable element; subsequent to a delivery of insulin accordingto one or more of the plurality of insulin delivery amounts, receiveblood glucose data from a blood glucose monitor; based at leastpartially on the received blood glucose data, identify a blood glucoselevel trend over a time period; and based at least partially on theidentified blood glucose level trend, automatically, without any userintervention, associate at one user selectable element of the pluralityof user-selectable elements with a new amount of carbohydrates.
 2. Theinsulin delivery system of claim 1, further comprising instructionsthat, when executed by the at least one processor, cause the mobiledevice to determine a new insulin delivery amount based at leastpartially on the new amount of carbohydrates associated with the oneuser selectable element.
 3. The insulin delivery system of claim 1,further comprising instructions that, when executed by the at least oneprocessor, cause the mobile device to: receive one or more user-specificdosage parameters; and based at least partially on the received one ormore user-specific dosage parameters, associate each of the plurality ofuser-selectable elements with the respective different amount ofcarbohydrates.
 4. The insulin delivery system of claim 1, furthercomprising instructions that, when executed by the at least oneprocessor, cause the mobile device to provide instructions to theinsulin delivery device to deliver insulin according to one of theplurality of insulin delivery amounts.
 5. The insulin delivery system ofclaim 4, further comprising instructions that, when executed by the atleast one processor, cause the mobile device to provide instructions tothe insulin delivery device to deliver insulin according to another ofthe plurality of insulin delivery amounts.
 6. The insulin deliverysystem of claim 1, wherein each of the respective amount ofcarbohydrates comprises an amount of carbohydrates in 5 gram or 10 gramincrements.
 7. The insulin delivery system of claim 1, wherein each ofthe respective amount of carbohydrates comprises is determined based atleast partially on one or more user-specific dosage parameterscomprising an insulin Sensitivity Factor (ISF), a Carb Ratio (CR), abody weight, an age and a total daily basal (TDB) rate of a person withdiabetes (PWD).
 8. The insulin delivery system of claim 1, furthercomprising a glucose monitor configured to monitor the blood glucoselevel of a person and provide the blood glucose data to the mobiledevice.
 9. The insulin delivery system of claim 1, wherein each of therespective amount of carbohydrates comprises an amount of carbohydratesdetermined based at least partially on postprandial blood glucose data.10. A method, comprising: determining insulin delivery amounts for eachof a plurality of user-selectable elements based at least partially onamounts of carbohydrates associated with each of the user-selectableelements; receiving blood glucose data; based at least partially on thereceived blood glucose data, identifying a blood glucose level trend;and based on the identified blood glucose level trend, automatically,without any user intervention, associating one or more of theuser-selectable elements with a new respective amount of carbohydrates.11. The method of claim 10, further comprising: determining a newinsulin delivery amount based at least partially on the new respectiveamount of carbohydrates associated with the one or more of theuser-selectable elements.
 12. The method of claim 10, furthercomprising: receiving one or more user-specific dosage parameters; andbased at least partially on the received one or more user-specificdosage parameters, associate each of the plurality of user-selectableelements with a respective different amount of carbohydrates.
 13. Themethod of claim 10, further comprising providing instructions to aninsulin delivery device to deliver insulin according to an insulindelivery amount of the insulin delivery amounts.
 14. The method of claim11, further comprising providing instructions to an insulin deliverydevice to deliver insulin according to the new insulin delivery amount.15. The method of claim 10, further comprising: receiving a userselection to deliver insulin, the user selection comprising a fail-safeprocedure; and responsive to the user selection, providing instructionsto an insulin delivery device to deliver insulin according to an insulindelivery amount of the insulin delivery amounts.
 16. The method of claim10, further comprising: receiving a user selection to deliver insulin,the user selection comprising a plurality of taps or gestures from auser; and responsive to the user selection, providing instructions to aninsulin delivery device to deliver insulin according to an insulindelivery amount of the insulin delivery amounts.
 17. The method of claim10, wherein determining insulin delivery amounts for each of theplurality of user-selectable elements comprises determining the insulindelivery amounts based at least partially on one or more of the amountof carbohydrates associated with the respective user-selectable elementdivided by a person with diabete's (PWD's) carbohydrate-to-insulinratio, a difference between a current blood glucose level and a targetblood glucose level divided by the PWD's insulin sensitivity factor, areading from a blood glucose meter (BGM), data from a continuous glucosemonitor (CGM), data from a flash glucose monitor, blood glucose trenddata, Insulin on Board (IOB) data, Carbohydrates on Board (COB) data,whether the PWD is or plans to exercise, whether the PWD is sick,whether the PWD is pregnant, and whether the PWD is experiencing menses,or whether the PWD has consumed certain medications.
 18. One or morenon-transitory, computer-readable media containing instructions that, inresponse to being executed by one or more processors, cause a mobiledevice to perform operations comprising: display a plurality ofuser-selectable elements on a user interface of the mobile device,receive a user selection of a user selectable element of the pluralityof user-selectable elements; subsequent to communicating an insulinbolus level associated with the selected user-selectable element to aninsulin delivery device, receive postprandial blood glucose data from ablood glucose monitor; and based at least partially on the receivedpostprandial blood glucose data, automatically, without any userintervention, associate a carbohydrate level with at least the selecteduser-selectable element of the plurality of user-selectable elements.19. The computer-readable media of claim 18, further comprisinginstructions that, executed by one or more processors, cause a mobiledevice to: determine a new insulin bolus level based at least partiallyon the carbohydrate level associated with at least the selecteduser-selectable element of the plurality of user-selectable elements;and communicate the new insulin bolus level to the insulin deliverydevice.
 20. The computer-readable media of claim 18, further comprisinginstructions that, executed by one or more processors, cause a mobiledevice to responsive to the user selection of the user selectableelement, providing instructions to the insulin delivery device todeliver insulin according to an insulin delivery amount.